The FDA Guerillas of Wonky DrugWonks - Part II

The FDA Guerillas of Wonky DrugWonks - Part
II

The tribe of
Guerillas operating a Big Pharma public relations firm under
cover of the Center for Public Integrity in Medicine may
soon be on the path to extinction and the blogs on DrugWonks
by the two out-of-control top bananas will likely be cause.

Former FDA officials from the Bush Administration
organized this industry funded front group a few years ago
and made Peter Pitts, President, and Robert Goldberg, Vice
President. DrugWonks is the defacto media outlet used to
distribute information over the internet as a services to
drug company clients of the public relations firm Manning
Selvage and Lee, where Mr Pitts is Senior Vice President of
Global Affairs.

In a September 1, 2006 posting, Mr Pitts
bragged that DrugWonks received over 100,000 visits in
August 2006. “And considering we’re not a “mass”
blog, we think that’s pretty terrific,” he
noted.

“According to Technorati (the folks who measure
blog audience numbers) of the 55 million blogs out there,
drugwonks.com has cracked the elite top 100,000. We're
Number 92,165,” he reported on December 22, 2006.

A
partial list of Big Pharma loyalists who have served, or
currently serve, in the Bush Administration’s FDA, can be
found in a June 30, 2006 blog, in which Mr Pitts provides
the details of what he described as the "memorable launch
party" for “the Center for Medicine in the Public Interest
(the public policy home of drugwonks.com.)”

Memorable
for many reasons, he said, but mostly because of who
attended. The attendees included FDA Deputy Commissioners,
Janet Woodcock and Dr Scott Gottlieb. That would be the Dr
Gottlieb who was recruited for a job at the FDA from MS&L,
before moving on to employment with the drug company
Novartis.

Anna Barker, the deputy director of the National
Cancer Institute, also attended the bash, along with Julie
Goon, described by Mr Pitts as "the new White House health
care policy guru."

Referred to as a "former FDA
colleague," Daniel Troy, former chief counsel of the FDA,
best known as the Godfather of Preemption, was at the party
and serves on the CMPI advisory board. He recently landed a
top job with MS&L client GlaxoSmithKline.

John Taylor, the
former National Institute of Mental Health director, now a
CMPI board member, also attend the grand-opening, along with
Dr Fred Goodwin, who sits on a CMPI board and belongs to a
gang of academic quacks paid by the makers of SSRI
antidepressants like Paxil, Prozac and Zoloft, to sign their
names to bogus studies misrepresenting the efficacy of the
drugs and concealing the suicide risks.

The keynote
speaker for the kick-off party was former FDA Commissioner,
Mark McClellan, described by Mr Pitts as, "the hardest
working man in health care."

Slanderland in
cyberspace

Mr Pitts and Mr Goldberg operate as a
two-man Guerilla hit squad on DrugWonks. Its their job to
recognize any reports in the media that could be damaging to
the FDA, or negatively effect Big Pharma profits, and
publish a response to discredit or distort the story and
lessen the impact.

They keep a running tab of all persons
who represent a threat to Big Pharma with some of the most
highly respected medical experts in the world at the top of
their hit list. New enemies are added all time and among
those regularly attacked are lawmakers on the powerful
committees in Congress that oversee health care, career
scientists at the FDA, reporters who write damaging
articles, and public health advocates.

The mere mention of
a “Black Box Warning,” is a threat to drug profits and
requires immediate damage control. For instance, on October
24, 2005, in response to a request by the consumer safety
group, Public Citizen, for a black box warning on erectile
dysfunction drugs, Mr Pitts ridiculed the leader of group by
writing:

“Sidney Wolfe, Public Citizen’s
General Secretary of Junk Science has just filed a
Citizen’s Petition with the FDA calling for a Black Box
warning on ED medications because of 48 events of NAION
(non-arteritic ischemic optic neuropathy, a loss of vision
that is frequently irreversible).
“

“Suggesting that Sidney have his eyes
examined would only be a partial diagnosis,” Mr Pitts
wrote in the blog.

He was particularly annoyed over Dr
Wolfe saying FDA “has once again failed in this
responsibility. These drugs need much stronger warnings,
especially a black box warning such as the one we have
proposed.”

“USA Today” was attacked on November 15,
2007, under the headline: "USA Today Adds Its Own Avandia
Warning," for quoting FDA career scientist, Dr David Graham,
when discussing the cardiac risks of GlaxoSmithKline’s
diabetes drug, Avandia, instead of talking to the FDA
official from the CMPI team. "Here's USA Today crawling
through the mud -- past Janet Woodcock who officially speaks
for the FDA -- to talk to David Graham about Avandia," Mr
Goldberg wrote.

Road to Extinction

In a July 30,
2008 blog, Mr Pitts seemed really rattled over a story by
Alicia Mundy in the Wall Street Journal with some pretty
good hints that the tribe of CMPI Guerillas promoting Big
Pharma’s agenda, with the help of industry insiders at the
FDA, might soon be on the path to extinction, when reporting
that:

“Powerful members of Congress want to
remake the Food and Drug Administration by giving it broad
powers to levy fines, order drug recalls and restrict
drug-industry advertising.”

Leading the
drive are Rep John Dingell (D Mich) and Senator Chuck
Grassley (R Iowa), she said. “Perhaps most importantly,
they want the next president to appoint a tough FDA
commissioner completely independent from the industry,” Ms
Mundy reported.

“To lay the groundwork
for their FDA overhaul,” Ms Mundy reports, “Messrs.
Dingell and Grassley and their allies have ordered about 20
investigations of drugs and issues involving the
FDA.”

“Mr. Grassley began his campaign to overhaul the
FDA in 2004 during an uproar about the agency's slow
reaction to potential links between popular antidepressants
and teen suicides,” she notes. “Now he has four staffers
and a parade of FDA whistleblowers helping him investigate a
plethora of FDA controversies, such as its approval of the
antibiotic Ketek,” she reports

Mr Pitts calls this
revelation about the opening of a new website to air
criticisms of top FDA officials, “some really shoddy
reporting”:

“Some current and former FDA
safety reviewers have opened a whistleblower website to air
their concerns that FDA leaders are pushing them to approve
some drugs”

He points out that this site
defines itself as “a website launched and operated by
current and former US Food and Drug Administration staff who
believe public health is being put at unnecessary risk.
These concerned civil servants and ex-civil servants have
either experienced or are aware of wrongful directives by US
FDA upper management – directives that put public health
at avoidable risk.”

Apparently Mr Pitts took the time to
check it out and found Jim Dickinson, who is not a former
FDA employee, registered the website, and is a “long-time
FDA antagonist,” he says. But then Mr Pitts is a
“long-time antagonist” of Senator Grassley and
whistleblowers as well. He can be found taunting the Senator
on DrugWonks as early as November 18, 2005, in calling him,
“the new father-confessor of disgruntled FDA employees.”

On February 21, 2008, he posted the headline, “Not the
real FDA – a Grahamatization,” in highlighting what he
described as an, “Interesting omnibus piece from by Warren
Ross of Medical Marketing & Media on the various slings and
arrows being tossed at the worlds premier medical regulatory
agency,” in which Mr Pitts just happens to be
quoted.

“Here’s what I had to say,” he writes in the
blog, “about the David Grahmatization of the whistleblower
culture:”

Pitts also takes a dim view of
people who go outside the agency to complain. A
professional, he maintains, should not “weep and whine and
try to get decisions made that are based on politics rather
than on science.” Whistleblowers, he acknowledges, at
least deserve “grudging respect” for letting it be known
who they are, “but what is truly damaging are the silent
leakers” who try to force political pressure on FDA
decisions. “The motive may be either to get drugs approved
or not approved—it cuts both ways.”

Mr Pitts seemed
particularly riled up over Ms Mundy’s report that Senator
Grassley believes the FDA Office of New Drugs has been
compromised by its relations with industry lobbyists, and
among them “former top FDA officials.”

“And
what does that mean?” He demands to know on DrugWonks.
“Any evidence to back up such blowhard accusations?”
He asks in his blog.

FDA officials "are too cozy with
the companies they regulate," Senator Grassley told the
Journal, and new leadership must "fix the
culture."

“What does “too cozy” mean?” Mr Pitts
asks in his blog. “Really, what does it mean?”
He demands to know.

Industry insider protection by
DrugWonks

Mr Goldberg identified three cozy FDA
officials that lawmakers wanted gone in a blog on February
20, 2008, when responding to what he described as “Anna
Mathews puff piece” on Bart Stupak, the Michigan
Democratic Congressman, in the Wall Street Journal.

"The drug
companies know that this administration ... will do nothing
to them. There is no fear of the FDA. With this culture with
laissez faire oversight and regulation, I think they should
be gone. If we get rid of them, it will put the drug
companies on notice."

On April 23, 2008, in
the midst of the Heparin scandal, Mr Goldberg ran the
headline: “Heparin Hypocrisy - Hyped Up Safety Fears on
ADHD Drugs - Does Medicaid Kill Poor People,” and wrote:
“Yet another show trial held by another congressional
committee on the FDA...There have been four or five over the
last two months on heparin alone.”

“Andy von
Eschenbach,” he said, “who is gaining momentum, along
with the FDA, in shifting the agency towards a science and
systems based approach to regulation -- using real time
technology to promote full time compliance -- has to sit and
take the following from the likes of Bart Stupak
(D-Michigan):”

"Last year, this nation's
regulatory failures resulted in dead dogs and cats. This
year, it has tragically led to the deaths of people," said
Rep. Bart Stupak, D-Mich. "If we don't make some rapid
progress on fixing the foreign drug inspection program, the
next melamine or heparin tragedy will soon be upon
us."

“That's rich,” Mr Goldberg said,
“coming from a guy who helped push up the suicide rates by
scaring parents away from antidepressants. and who is
pushing for drug importation at a time when Al Qaeda and
Hezbollah are involved in drug counterfeiting.”

“Andy
must have to shower after sitting through such a show
trial,” he added.

“Meanwhile the Steve Nissen fear
factory spews out another piece of tabloid medicine: EKG
monitoring of all kids getting stimulants for ADHD,” Mr
Goldberg continued, referring to the world-renowned
cardiologist from the Cleveland Clinic.

“Now there's a
way to achieve Nissen (who has never studied ADHD) goal of
making a physician's hand quiver before writing a scrip for
the drug,” he wrote.

Evidence of “cozy”
relationships can also be found in the names of the guests
at the "memorable launch party." On August 24, 2005, Mr
Pitts pumped out syrupy defense when the Seattle Times
criticized the FDA’s hiring of industry insider, Scott
Gottlieb, directly from the MS&L stable. Without mentioning
that he also was employed by MS&L, Mr Pitts
wrote:

“Scott Gottlieb is a lot of things.
Public servant. Physician. Pundit. He is my former colleague
at the FDA. Most importantly, he is my friend.”

“And
my blood boils with anger and frustration at today’s
scurrilous attack on him in the Seattle Times“.

“Scott I know personally. I know that he takes his work
at the FDA seriously. I know that he takes his government
oath to protect the public health seriously. I know that he
is highly ethical and honest. And I know how much this
article must hurt him personally.”

“And, I’m sure,
that is precisely why certain lupine elements are gleefully
forwarding this ugly hit piece to their friends and
colleagues.”

“That they have chosen character assassination only
shows the weakness of their intellectual arguments as well
as their disappointing lack of character,” he
wrote. “For shame.”

On January 15, 2006, Dr Sidney
Wolf, was again ridiculed when the LA Times cited his
criticisms of what Mr Pitts described as the FDA’s “new
and better way to establish drug safety that solves a one of
the more serious problems in drug development, namely that
animal studies are often a poor and inaccurate substitute
for what happens in human.”

The “better way”
involved earlier testing on humans. Dr Wolf questioned
whether the FDA had a strong enough scientific argument for
speeding the early stages of drug research, the Times noted.

In his blog, Mr Pitts dismisses the legitimacy of Dr
Wolf’s concerns with the statement: “Sid Wolfe has
opposed every effort to speed drugs to dying patients since
he has been on his anti-patient jihad starting in 1970.”

“Wolfe has a self-interest in trashing new
medicines,” he also explained, “since his organization
makes money by hawking a book Worst Pills, Best Pills that
argues the most drugs are dangerous.”

Blowhard
accusations

The majority of proof to support Senator
Grassley‘s “blowhard accusations,” will likely come
directly from the CMPI website and the years of
incriminating blogs by Mr Pitts and Mr Goldberg filled with
nothing but lobbying campaigns for the drug
companies.

Rarely does a month pass where the two top
bananas are not pumping out propaganda to boost profits for
MS&L clients Eli Lilly, Glaxo and Pfizer, with false claims
that SSRIs are effective and do cause suicide, along with
vicious attacks on anyone who says otherwise.

On February
15, 2008, Mr Goldberg was again blaming a non-existent
decline in the prescribing of SSRIs, and the increased
suicides, on Rep Stupak, as head of the Health subcommittee
on Energy Commerce. He held "several fear-drenched hearings
about antidepressants in 2003-2004," and he "is partially
responsible for the decline in SSRI prescription use and the
corresponding increase in adolescent suicide," Mr Goldberg
wrote. “So the question is,” he said:

“And this guy is head of the Health
subcommittee? Why is he being taken seriously? Why isn't he
being held accountable?”

In the blog, Mr
Goldberg includes the following statements made by Rep
Stupak a hearing, which he claims are “scientifically
incorrect,” “misleading” and
“dangerous”:

"SSRI’s have not been
proven effective in treating adolescent depression. To the
contrary their use may actually increase the suicide rate of
its young patients.

"In response to these reports of
increased suicide rates with SSRI use, FDA officials
suppressed their own post marketing surveillance, prohibited
FDA employees from discussing the report, and launched an
investigation to find the person who leaked information to
the press. Today, SSRIs remain on the market without a clear
medical benefit to the patient."

"There
should be a black box warning around everything Stupak says
regarding medicines," Mr Goldberg declares, "particularly
SSRIs which have been shown to benefit patients and are
associated with a decline in suicides."

Prolific smear
campaigns are directed at medical experts who testify
against Big Pharma in litigation or government hearings. A
life-time reputation of credibility and high regard may be
targeted for assassination as punishment for this capital
crime. Attempts to destroy the reputation of Dr David Healy,
the world-famous expert on psychopharmacology, with 20 books
to his name, appear frequently on DrugWonks. For instance,
on December 19, 2006, Mr Pitts wrote:

"Dr.
Healy recently testified at the FDA hearing on
antidepressants. He is a psychiatry professor at Cardiff
University in Wales but also, according to the New York
Times, has worked for plaintiff's lawyers in cases brought
against pharmaceutical companies. That's
transparency."

"When I served as Associate
Commissioner at the FDA, Dr. Healy visited with me -- but he
never mentioned that he worked for the tort bar," Mr Pitts
said. "That's dishonesty."

The untold story here is that
Dr Healy traveled to Washington on his own dime in 2004, for
the meeting of the FDA Advisory Committee to consider the
suicide risks of SSRIs. During his visit, Dr Healy and a
group of people that included parents of children who
committed suicide while taking SSRIs, also met with Mr Pitts
and other FDA officials.

As a follow-up to the meeting,
Dr Healy prepared a lengthily report with summaries of all
the available suicide data on each SSRI, including his own
studies, and sent copies to Mr Pitts and the other FDA
officials, free of charge. Dr Healy’s trip to Washington
to testify at the advisory committee meeting in December
2006, was also on his own dime.

In an email, Dr Healy was
asked whether he would like to respond to the above
allegations by Mr Pitts on DrugWonks. In a return email, Dr
Healy explained that he consults as an expert in litigation
for drug companies and trial lawyers alike, and wrote:

"When I went into the FDA to meet with Peter
Pitts, I made no efforts to conceal my links to trial
attorneys - some of whom were at the meeting - and no
efforts were made to conceal my links to the pharmaceutical
industry, all of which were well known."

"I
went," he said, "because in my experience Republicans such
as Senator Grassley and staffers working for them such as
Emilia DeSanto have appeared more concerned about and more
effective on the issue than anyone else and as a Republican
appointee I thought Peter Pitts' heart might be in the right
place."

"What was not well-known at the time was that
Peter Pitts was transiting between working for
pharmaceutical companies - or perhaps not even transiting,"
Dr Healy wrote. "I'm not sure how many of us would have felt
it worth going if we had known his background," he
noted.

"Retrospectively," Dr Healy says, "it seems
astonishing to me now that with people like Peter Pitts in
FDA that it was ever possible to bring the suicidality
issues to light."

It seems even more astonishing after
reading Mr Goldberg’s blog on February 15, 2008, which
declares: “And again, there is no link to SSRIs and in
increase in suicides, rather some unclear evidence based on
an unvalidated measure called suicidality that includes just
talking about self harm in general.”

On March 9, 2008,
Mr Goldberg called Dr Healy an expert "whose flawed study
about SSRI's and suicide triggered a series of events which
lead to less SSRI use and more suicide.”

However, on
July 24, 2008, Pharmalot’s Ed Silverman reported on data
just released by the Agency for Healthcare Research and
Quality, a unit of the US Health and Human Services
Department that showed antidepressant prescriptions rose in
2005.

“The increase amounted to roughly 10 percent, and
that occurred in a year in which new and controversial Black
Box warnings were added to the labeling on the
medications,” he wrote.

In addition, government
statistics for 2005, the year the warnings were added, show
there was no increase in suicides. In fact, suicide deaths
were down in all age groups. For children aged 5 to 14,
there were 285 in 2004, and 270 in 2005. In young people
aged 15 and 24, the number of suicides was 4,316 in 2004,
and dropped to 4,139 in 2005.

Mountains of evidence

Much more evidence can able found in blogs beginning
on December 10, 2007, which was another a memorable day at
CMPI, when Mr Pitts announced that CMPI would present a new
award called "The Golden Clipboard," to those "who stand in
the way of medical progress."

Those "who stand in the way
of medical progress," refers to persons involved in exposing
the FDA’s failure to protect the public from drugs such as
the diabetes drug Avandia, Vioxx, and SSRI antidepressants,
due to cozy relationships with the makers of the drugs.

CMPI published the names for the top award, and the
runner-up winners of the Bronze Clipboard and Silver
Clipboard on DrugWonks on December 21, 2007, along with
comments about why they were chosen.

The highest honor
went to Dr Graham: "For his persistence, zeal, and
determination to damage not only the FDA but the public
health, for his effectiveness in fear mongering and
willingness to subordinate medical progress to his ascetic
view of safety."

"David Graham ostensibly works for the
FDA," Mr Pitts said, "but he seems to spend a lot of time in
the Halls of Congress advising members and staff about which
FDA medical reviewers should be hauled in for polite
'conversations.'"

"Setting aside Dr. Graham’s
contribution to the Vioxx Populi literature -- which an FDA
advisory committee considered to be a rather shoddy piece of
research – he also helped push through the statistical
analysis and organize the public outcry over SSRIs that
resulted in a decline in antidepressant use and a
corresponding increase in teen suicides," he explained.

Mr
Pitts also credited Dr Graham for "his assertion that
Avandia should be taken off the market," and said, Dr Graham
is AKA (also known as) “Dr. Precautionary
Principle.”

The Bronze award went to California
Democratic Congressman Henry Waxman, who "is best remembered
in 2007 as the conduit for Steve Nissen’s half-baked
meta-analysis of Avandia," Mr Pitts pointed out.

His
oversight hearing "helped blow out of all appropriate
proportion fear about drug safety in general and Avandia in
particular," the blog said.

Dr Nissen had to settle for
the Silver Clipboard, but his "persistent undermining of the
FDA came close to winning him Clipboard top honors for
2007," Mr Pitts pointed out.

Many of the blogs leading up
to the awards seemed to indicate that Dr Graham, Dr Nissen
and Rep Waxman were locked in a tight race. But a review of
all the blogs on DrugWonks clearly showed that Senator
Grassley was never ruled out as the top contender.

For
instance, on August 20, 2005, Mr Pitts ran the headline:
"Leaves of Grassley. Not a Whit of Sense," and referred to
Mr Grassley as the "Senator from Blameland," and "Body Slam
Chuck, the King of Destructive Criticism."

Mr Pitts was
annoyed over the Senator's comments about the FDA after
Merck lost the first Vioxx trial, in stating: “The Food
and Drug Administration was also negligent in the Vioxx case
… Those running the nation’s public safety agency
repeatedly dismissed the concerns of their own scientists
and seemed to do everything possible to keep the public in
the dark about emerging problems with Vioxx.”

"And talk
about bellying up to the tort bar!" Mr Pitts wrote. "I
wonder how much more money the Senator will get from the
trial lawyer lizards as a reward for such vituperative
rants?"

Of course, he failed to mention that the
contributions by the “lizards” could never match the
money doled out on Capitol Hill every year by the
pharmaceutical industry.

Mr Goldberg’s April 18, 2007,
blog pretty much preannounced the winner with the headline:
"David Graham: Public Health Enemy," and the statement
that:

"Members of Congress and senior
officials of the FDA should be ashamed of themselves for
giving Graham the chance to not only rant on about Vioxx and
SSRIs but to make the same claims about Ketek and drugs for
schizophrenia."

But all the Clipboard winners
should feel equally honored by the CMPI awards, because
judging by the number of slanderous attacks they each
received, their combined efforts to expose drug safety
issues and fix the broken FDA are obviously what's
working.

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